Insights On Quality Assurance

1. OPTIMA 7000 Fill Line 6/7/2021

   Ajinomoto Bio-Pharma Services is a leader in aseptic filling, offering a wide range of capabilities for vials with our OPTIMA 7000 fill line. The OPTIMA VFVM 7000 safely processes various types and classes of biopharmaceutical products in 2 mL to 100 mL sizes.

2. What Are The Measurable Benefits Of Modern MES Software? 11/21/2022

   Even a small amount of paper on the factory floor carries hidden costs in impeded throughput, productivity, and on-time shipment. Explore the benefits of a modern MES software solution.

3. Supplier Quality Agreements 101: What, Who, And Why? 9/14/2021

   Quality agreements with suppliers can go a long way to demonstrating the kinds of control that medical device manufacturers have over their suppliers.

4. Specialty Pharma Connects Content Management And Regulatory Compliance 2/3/2022

   A European specialty pharmaceutical business deployed a fully integrated, closed-loop document management system that also addresses the quality and compliance requirements of regulatory bodies.

5. 6 Steps To Simplify Software Validation 10/4/2022

   Six steps to reducing the time, pain, and expense of the software validation process while maintaining quality and safety.

6. Biological Indicators - Population Assay 10/7/2022

   Watch this discussion to learn about resistance testing and using it to control and monitor incoming biological indicators (BI).

7. Automating Document Control Processes To Comply With FDA And ISO Requirements 8/25/2021

   Your document control system should be agile and scalable to keep up with the changing regulatory landscape. Here, we detail the guidelines and standards that apply, and illustrate how digitizing document control processes is essential for ongoing compliance.

8. Aseptic Vial Filling 6/18/2021

   We offer a unique range of formulation and aseptic filling in vials, prefilled syringes or cartridges to address production needs that span from small early stage clinical products to larger scale commercial products.

9. Modernizing Biopharma Manufacturers To Improve Quality And Safety 1/10/2022

   Read how proven, scalable digital solutions to modernize pharmaceutical product innovation and development gives enterprises an edge in meeting the manufacturing guidelines for pharmaceuticals while elevating the entire industry.

10. The New Approach To QbD For Oral Solid Manufacturing 9/26/2022

    Learn how APD can help you maximize the understanding of the influences of the critical process parameters and their interactions with the material properties.